Proamatine

"The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical"...

Proamatine

INDICATIONS

ProAmatine® (midodrine hydrochloride) is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because ProAmatine® (midodrine hydrochloride) can cause marked elevation
of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients
whose lives are considerably impaired despite standard clinical care, including
non-pharmacologic treatment (such as support stockings), fluid expansion, and
lifestyle alterations. The indication is based on ProAmatine® (midodrine hydrochloride) 's
effect on increases in 1-minute standing systolic blood pressure, a surrogate
marker considered likely to correspond to a clinical benefit. At present, however,
clinical benefits of ProAmatine® (midodrine hydrochloride) , principally improved abitlity
to perform life activities, have not been established. Further clinical trials
are underway to verify and describe the clinical benefits of ProAmatine® (midodrine hydrochloride)
.

After initiation of treatment, ProAmatine® (midodrine hydrochloride) should be continued only
for patients who report significant symptomatic improvement.

DOSAGE AND ADMINISTRATION

The recommended dose of ProAmatine® (midodrine hydrochloride) is 10 mg, 3 times daily. Dosing
should take place during the daytime hours when the patient needs to be upright,
pursuing the activities of daily living. A suggested dosing schedule of approximately
4-hour intervals is as follows: shortly before, or upon arising in the morning,
midday and late afternoon (not later than 6 P.M.). Doses may be given in 3-hour
intervals, if required, to control symptoms, but not more frequently. Single
doses as high as 20 mg have been given to patients, but severe and persistent
systolic supine hypertension occurs at a high rate (about 45%) at this dose.
In order to reduce the potential for supine hypertension during sleep, ProAmatine® (midodrine hydrochloride)
should not be given after the evening meal or less than 4 hours before bedtime.
Total daily doses greater than 30 mg have been tolerated by some patients, but
their safety and usefulness have not been studied systematically or established.
Because of the risk of supine hypertension, ProAmatine® (midodrine hydrochloride) should be
continued only in patients who appear to attain symptomatic improvement during
initial treatment.

The supine and standing blood pressure should be monitored regulary, and the
administration of ProAmatine® (midodrine hydrochloride) should be stopped if supine blood pressure
increases excessively.

Because desglymidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically
studied, it is recommended that treatment of these patients be initiated using
2.5-mg doses.

Dosing in children has not been adequately studied.

Blood levels of midodrine and desglymidodrine were similar when comparing levels
in patients 65 or older vs. younger than 65 and when comparing males vs. females,
suggesting dose modifications for these groups are not necessary.

HOW SUPPLIED

ProAmatine® (midodrine hydrochloride) is supplied as 2.5-mg, 5-mg and 10-mg tablets for oral
administration. The 2.5-mg tablet is white, round, and biplanar, with a bevelled
edge, and is scored on one side with “RPC” above and “2.5”
below the score, and “003” on the other side. The 5-mg tablet is
orange, round, and biplanar, with a bevelled edge, and is scored on one side
with “RPC” above and “5” below the score, and “004”
on the other side. The 10-mg is blue, round, and biplanar, with a bevelled edge,
and is scored on one side with “RPC” above and “10”
below the score, and “007” on the other side.